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EP1476138B8 - Formulations a liberation modifiee d'au moins une forme de tramadol - Google Patents

Formulations a liberation modifiee d'au moins une forme de tramadol Download PDF

Info

Publication number
EP1476138B8
EP1476138B8 EP03743147A EP03743147A EP1476138B8 EP 1476138 B8 EP1476138 B8 EP 1476138B8 EP 03743147 A EP03743147 A EP 03743147A EP 03743147 A EP03743147 A EP 03743147A EP 1476138 B8 EP1476138 B8 EP 1476138B8
Authority
EP
European Patent Office
Prior art keywords
tramadol
release formulations
modified release
polyglycol
melting point
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP03743147A
Other languages
German (de)
English (en)
Other versions
EP1476138A2 (fr
EP1476138B1 (fr
EP1476138A4 (fr
Inventor
Pawan Seth
Paul J. Maes
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Valeant International Bermuda
Original Assignee
Valeant International Barbados SRL
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=27765948&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP1476138(B8) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Valeant International Barbados SRL filed Critical Valeant International Barbados SRL
Priority to SI200332108T priority Critical patent/SI1476138T1/sl
Publication of EP1476138A2 publication Critical patent/EP1476138A2/fr
Publication of EP1476138A4 publication Critical patent/EP1476138A4/fr
Publication of EP1476138B1 publication Critical patent/EP1476138B1/fr
Priority to CY20121100144T priority patent/CY1112517T1/el
Application granted granted Critical
Publication of EP1476138B8 publication Critical patent/EP1476138B8/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/155Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A61P29/02Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pain & Pain Management (AREA)
  • Emergency Medicine (AREA)
  • Rheumatology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Cosmetics (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Paints Or Removers (AREA)
EP03743147A 2002-02-21 2003-02-21 Formulations a liberation modifiee d'au moins une forme de tramadol Expired - Lifetime EP1476138B8 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
SI200332108T SI1476138T1 (sl) 2002-02-21 2003-02-21 Formulacije s prirejenim sproščanjem vsaj ene oblike tramadola
CY20121100144T CY1112517T1 (el) 2002-02-21 2012-02-13 Φαρμακοτεχνικες μορφες τροποποιημενης αποδεσμευσης μιας τουλαχιστον μορφης τραμαδολης

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US35785102P 2002-02-21 2002-02-21
US357851P 2002-02-21
PCT/US2003/004866 WO2003072025A2 (fr) 2002-02-21 2003-02-21 Formulations a liberation modifiee d'au moins une forme de tramadol

Publications (4)

Publication Number Publication Date
EP1476138A2 EP1476138A2 (fr) 2004-11-17
EP1476138A4 EP1476138A4 (fr) 2008-05-07
EP1476138B1 EP1476138B1 (fr) 2011-12-07
EP1476138B8 true EP1476138B8 (fr) 2012-03-07

Family

ID=27765948

Family Applications (2)

Application Number Title Priority Date Filing Date
EP03743147A Expired - Lifetime EP1476138B8 (fr) 2002-02-21 2003-02-21 Formulations a liberation modifiee d'au moins une forme de tramadol
EP03743148.3A Expired - Lifetime EP1476139B1 (fr) 2002-02-21 2003-02-21 Formes posologiques à libération controlée

Family Applications After (1)

Application Number Title Priority Date Filing Date
EP03743148.3A Expired - Lifetime EP1476139B1 (fr) 2002-02-21 2003-02-21 Formes posologiques à libération controlée

Country Status (15)

Country Link
US (4) US7780987B2 (fr)
EP (2) EP1476138B8 (fr)
JP (3) JP5069395B2 (fr)
AT (1) ATE536173T1 (fr)
AU (2) AU2003211146B2 (fr)
CA (2) CA2476201C (fr)
CY (1) CY1112517T1 (fr)
DK (1) DK1476138T3 (fr)
ES (2) ES2627842T3 (fr)
MX (2) MXPA04008100A (fr)
NO (1) NO20043913L (fr)
NZ (2) NZ535456A (fr)
PT (1) PT1476138E (fr)
SI (1) SI1476138T1 (fr)
WO (2) WO2003072025A2 (fr)

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US8128957B1 (en) * 2002-02-21 2012-03-06 Valeant International (Barbados) Srl Modified release compositions of at least one form of tramadol
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AU2003211146B2 (en) 2007-07-19
NO20043913L (no) 2004-11-16
CA2476201A1 (fr) 2003-09-04
JP4704685B2 (ja) 2011-06-15
MXPA04008164A (es) 2005-05-17
US20080274177A1 (en) 2008-11-06
US7780987B2 (en) 2010-08-24
DK1476138T3 (da) 2012-02-20
WO2003072089A1 (fr) 2003-09-04
AU2003211145B2 (en) 2007-07-12
PT1476138E (pt) 2012-02-14
EP1476139A1 (fr) 2004-11-17
JP2005526047A (ja) 2005-09-02
EP1476138A2 (fr) 2004-11-17
EP1476139B1 (fr) 2017-05-17
US20130245154A1 (en) 2013-09-19
AU2003211146A1 (en) 2003-09-09
CA2476496C (fr) 2009-12-15
ES2377729T3 (es) 2012-03-30
SI1476138T1 (sl) 2012-07-31
US20040037883A1 (en) 2004-02-26
EP1476138B1 (fr) 2011-12-07
NZ535456A (en) 2006-08-31
EP1476138A4 (fr) 2008-05-07
JP2010155864A (ja) 2010-07-15
WO2003072025A2 (fr) 2003-09-04
AU2003211145A1 (en) 2003-09-09
JP5069395B2 (ja) 2012-11-07
WO2003072025A3 (fr) 2003-11-06
ES2627842T3 (es) 2017-07-31
JP2005526043A (ja) 2005-09-02
ATE536173T1 (de) 2011-12-15
EP1476139A4 (fr) 2007-12-26
CA2476201C (fr) 2009-09-01
MXPA04008100A (es) 2005-06-17
CA2476496A1 (fr) 2003-09-04
US20150030675A1 (en) 2015-01-29
NZ535455A (en) 2009-08-28
CY1112517T1 (el) 2015-12-09

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